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COMPLETED Phase 3

ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)

NCT04523129 · View on ClinicalTrials.gov ↗

Study Summary

The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

Conditions Studied

Interventions

  • DRUG CyclASol topical ocular, eye drops
  • DRUG Vehicle topical ocular, eye drops

Study Locations (20)

California

  • CYS-004 Investigational Site — Los Angeles
  • CYS-004 Investigational Site — Newport Beach
  • CYS-004 Investigational Site — Santa Ana

Indiana

  • CYS-004 Investigational Site — Carmel
  • CYS-004 Investigational Site — Indianapolis

Massachusetts

  • CYS-004 Investigational Site — Andover
  • CYS-004 Investigational Site — Raynham

Missouri

  • CYS-004 Investigational Site — Kansas City
  • CYS-004 Investigation Site — Kansas City

North Carolina

  • CYS-004 Investigational Site — Raleigh
  • CYS-004 Investigational Site — Shelby

Arizona

  • CYS-004 Investigational Site — Phoenix

Colorado

  • CYS-004 Investigational Site — Colorado Springs

Florida

  • CYS-004 Investigational Site — Fort Lauderdale

Trial Details

FieldValue
Enrollment Target 834 participants
Start Date 2020-12-05
Est. Completion 2021-10-08
Phase Phase 3

Sponsor

Novaliq

2 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT04523129

The ClinicalTrials.gov registry entry for NCT04523129 describes a study currently listed as completed. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 834 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novaliq, which has 2 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.

The record links to 1 condition, with Dry Eye Disease appearing as the primary indexed condition, and to 2 interventions — of which CyclASol topical ocular, eye drops is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.

Geographic footprint matters for practical reasons: NCT04523129 reports 20 study locations spanning 14 distinct geographic areas — top geographies include California, Indiana, Massachusetts. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.

Frequently Asked Questions

What is clinical trial NCT04523129 about?

NCT04523129 is a clinical study titled "ESSENCE 2: CyclASol for the Treatment of Signs and Symptoms of Dry Eye Disease (DED)". The objective of this pivotal trial is to assess the efficacy, safety and tolerability of CyclASol in comparison to the vehicle for the treatment of signs and symptoms of Dry Eye Disease (DED).

What is the current status of trial NCT04523129?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 834 participants. The study started on 2020-12-05. Estimated completion is 2021-10-08.

What conditions does trial NCT04523129 study?

This clinical trial studies the following conditions: Dry Eye Disease. These conditions were identified from the trial registry and reflect the primary focus areas of the research.

What interventions are being tested in trial NCT04523129?

The interventions under investigation include: CyclASol topical ocular, eye drops (DRUG), Vehicle topical ocular, eye drops (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.

Who is sponsoring clinical trial NCT04523129?

This trial is sponsored by Novaliq, which has 2 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.

Where is trial NCT04523129 being conducted?

This trial has 20 study locations across Arizona, California, Colorado, Florida, Illinois. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Related

Data sourced from official U.S. government datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial